GENEPATH DIAGNOSTICS INDIA PRIVATE · 89-08 · INDIA
For GENEPATH DIAGNOSTICS INDIA PRIVATE · 89-08 · INDIA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is INDIA; product is GenePath CoViSwift v3.0; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/24/2021; address is Above Phadkehospital , 4th Floor; Jangli Maharaj Road , Pune, Maharashtra INDIA, verified against its source on 2026-09-16.
- Firm
- GENEPATH DIAGNOSTICS INDIA PRIVATE verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- INDIA verified
- Address
- Above Phadkehospital , 4th Floor; Jangli Maharaj Road , Pune, Maharashtra INDIA verified
- Date published
- 11/24/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- GenePath CoViSwift v3.0 verified
What the source says
GENEPATH DIAGNOSTICS INDIA PRIVATE Date Published : 11/24/2021 Above Phadkehospital , 4th Floor; Jangli Maharaj Road , Pune, Maharashtra INDIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/24/2021 Desc: GenePath CoViSwift v3.0
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.